EudraVigilance Training
Electronic Reporting of ICSRs in the EEA
A joint initiative of the European Medicines Agency with
DIA acting as the conference organiser
Course ID #11595 | 27-29 June 2011
Training Centre of the National Bank of Greece, Glyfada, Greece
Course Goals
The primary goals of this course are to allow
participants to:
• Acquire a robust base in the fundamentals of the
electronic reporting of ICSRs
• Familiarise themselves with the electronic
transmission of ICSRs and the ICH M2 safety and
acknowledgment message specifications
• Understand and apply the ICH E2B(R2)
specifications on clinical safety data management in
the frame of good pharmacovigilance practices as
well as the current EudraVigilance Business Rules
• Get hands on experience with the EudraVigilance
reporting capabilities and query functions
Course Audience
The course is intended for people in charge of pharmacovigilance and drug safety in MAHs and National
Competent Authorities with legal reporting obligations
in the EEA. The target audience of this training course
also includes, but is not limited to:
•
•
•
•
•
Qualified persons for pharmacovigilance
Pharmacovigilance experts
Data entry professionals
Medical coding professionals
Persons interested in building or updating their
knowledge in electronic adverse reaction reporting
Details of the Course
New Format of this three day course with more time for
hands-on activities!
Introduction
EudraVigilance is the European data-processing network and management system, established at the
European Medicines Agency to support the electronic exchange, management and scientific evaluation of
Individual Case Safety Reports (ICSRs) related to all medicinal products authorised in the European
Economic Area (EEA).
EudraVigilance also incorporates signal detection and data analysis facilities and is therefore regarded as
one of the main pillars of the European Risk Management Strategy, which aims to strengthen the conduct
of pharmacovigilance in the EEA.
Community legislation is in place to ensure that all stakeholders, including National Competent Authorities
(NCAs), marketing authorisation holders (MAHs) and sponsors of clinical trials in the EEA collect, collate
and exchange adverse drug reactions.
The electronic transmission of ICSRs, based on the results of the International Conference on Harmonisation
of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) remains a priority
in the area of pharmacovigilance to make the adverse reaction data exchange and management more
efficient.
EVWEB is an Internet-based reporting tool developed by the European Medicines Agency to allow Small
and Medium Size Enterprises (SMEs) that hold marketing authorisations in the EEA and sponsors of clinical
trials, to report electronically adverse reactions, in full compliance with the internationally agreed standards
to the European Medicines Agency and NCAs.
The EudraVigilance Training Programme has been designed for:
•Organisations e.g. SMEs, (non-) commercial sponsors that intend to use EVWEB to implement
electronic transmission of safety data. Organisations intending to use EVWEB are required to follow
a training course to ensure the correct use of the reporting tool. They can apply for more than one
person to be trained, or alternatively, send one person who will subsequently train other users
internally in the organisation.
• Pharmaceutical companies that perform electronic transmission of ICSRs and use their locally
established ICH compliant data-processing network (Gateway) and management system, may wish
to attend this course to learn how to access and query the ICSRs that they have submitted to
EudraVigilance.
• National Competent Authorities that wish to acquire knowledge about the functionalities of the
tool, specifically in relation to data retrieval and evaluation to facilitate the scientific use of the data
contained in the database.
Duration: 3 days
Location: Training Centre of the
National Bank of Greece
41-43 Poseidonos Av.,
166 75 Glyfada
Greece
The course is limited to
25 participants. Register early.
Course Overview
This course is the only training programme officially recognised by the European Medicines Agency.
Participants that pass the competency assessment following the course will receive a certificate that will
allow them to register with EudraVigilance and to report ICSRs to the European Medicines Agency and/or
the National Competent Authorities in the EEA.
The EudraVigilance training programme is open to Contract Research Organisations (CROs), consultants
and other organisations with an interest in the EudraVigilance project. It should be noted that the persons
attending the training will only be given access to the EudraVigilance training environment for a period of
two months.
After this period the EudraVigilance system will only be available to those organisations that act on behalf
of a MAH, a Sponsor of a Clinical Trial or an NCA and that this is notified to the European Medicines through
the EudraVigilance registration process.
Note: The course will NOT address aspects related to the data entry of medicinal product information in the
EudraVigilance Medicinal Product Dictionary (EVMPD).
Personnel of organisations responsible for entering medicinal product data in the EVMPD need to attend
the EVMPD training course.
2
COURSE AGENDA
DAY ONE
Module I: Fundamentals of Electronic Reporting of ICSRs
09:00
13:30
Receiving Acknowledgment Messages
Introduction
Session 1
Concepts of Electronic Transmission of ICSRs.
Introduction to EudraVigilance
Registration with EudraVigilance
Session 14
Validation and Creating Acknowledgments
15:30
Session 16
What To Do in the Event of System Failure
Coffee Break
Session 3
EudraVigilance Gateway and WEB Trader
Session 4
ICSR Validation Business Rules
Coffee break
Session 15
WEB Trader - Post Function
Session 2
Clinical Safety Data Management and
Transmission of ICSRs - ICH E2B(R2)
10:30
Session 13
17:45
End of day 2
DAY THREE
Module III: Query Functions, MedDRA in EudraVigilance
12:30
Lunch
09:00
Module II: Creating and Validating ICSRs
13:30
Session 5
Creating a Safety Message
15:30
Coffee break
Session 6
Follow-up Report
Session 7
Nullification Report
18:00
Session 17
MedDRA Simple and Advanced Queries
Session 18
ICSR Simple and Advanced Queries
10:30
Coffee break
Questions and review for competency assessment
12:00
Lunch
Module IV: Competency Assessment
Session 8
Literature Report
Competency Assessment
End of day 1
• Part 1: Multiple Choice Questions
• Part 2: ICSR Exam Case
15:00
Questions
16:00
End of day 3
DAY TWO
Module II: Creating and Validating ICSRs (cont’d)
09:00
Session 9
Parent-child Report
09:45
Session 10
Report with Medical and Drug History
10:30
Coffee break
Session 11
Study Report
EudraVigilance Business Rules
Session 12
Saving and Printing Options
12:30
Lunch
Unless otherwise disclosed, DIA acknowledges that the statements made
by speakers are their own opinion and not necessarily
that of the organisation they represent, or that
of the Drug Information Association.
3
Learning Objectives
What this Training Course Is
By the end of this training course, you should be able to do
the Following within the context of EudraVigilance:
• Apply ICH rules to safety reporting
• Describe the Registration process with EudraVigilance
• Understand the Concepts of Electronic Transmission of ICSRs
• Describe the EudraVigilance Gateway
• Describe the WEB Trader functions
• Explain the reporting processes for fully-automated
organisations, Post-function users, and EVWEB users
• Create, validate and send safety messages
• Create, validate and send:
• Follow-up reports
• Nullification reports
• Literature reports
• Parent-child reports
• Study reports
• Reports with medical and drug history
• Apply EudraVigilance business rules
• Create and send acknowledgments of received ICSR messages
• Query, view, browse and download safety reports
• Query, view and browse MedDRA through the EVWEB
It is important that you have the proper expectations of what will be covered in this course. This course is:
Training on the EudraVigilance system, specifically the EVWEB
• How the system relates to the ICH E2B(M) guideline
• How to navigate the system
• How to enter information
• Mandatory fields
Training on the WEB Trader for transmission of documents on the
EudraVigilance Gateway
Instruction on using EVWEB to browse MedDRA
What this Training Course Is Not
It is important that you have the proper expectations of what will not be
covered in this course. This course is not:
Training on pharmacovigilance practices
Consulting on your company's business rules
MedDRA training
Training on data entry of the EudraVigilance Medicinal Product
Dictionary (EVMPD)
Course Pre-requisites
Hotel and Flight Information
Participants are expected to have a minimal background knowledge of:
Please contact Alice Travel to book a hotel room, flight or airport
transfer. They are happy to assist you.
• EU Community legislation and guidance documents related to the
monitoring of safety of clinical trials and post-authorisation
pharmacovigilance activities
http://eudravigilance.emea.europa.eu/human/euPoliciesAndDocs.asp
ALICE TRAVEL
3, Lekka Street
Athens 10563
GREECE
• Working with a PC
Tel: +30 2103235185
Fax: +30 2103230423
For newcomers in Pharmacovigilance, a special 1 day course
“Introduction to PharmacoVigilance” has been developed. Please
consult the DIA website for more information.
Course Information
The course will take place at:
Training Centre of the National Bank of Greece
41-43 Poseidonos Av.,
166 75 Glyfada
Greece
Email: [email protected]
Website: www.alicetravel.gr
REGISTRATION FORM
ID# 11595
EudraVigilance - Electronic Reporting of ICSRs in the EEA
27-29 June 2011| Training Centre of the National Bank of Greece
FAX YOUR COMPLETED REGISTRATION FORM TO
ALICE TRAVEL - 3, Lekka Street - Athens 10563 - GREECE
Tel: +30 2103235185 - Fax: +30 2103230423 - Email: [email protected] - Website: www.alicetravel.gr
Each course is limited to 25 participants. The registration fee includes training course material, IT equipment, lunch and refreshments. The
course may be cancelled if numbers of participants are not sufficient.
EUR 1'550.00 EUR 775.00 Standard Fee
Reduced Fee for Academia and Full Government
Applicable VAT will be added.
Special discount for SME (status confirmed by EMA) available. Multiple course discount available if booked together with following EVMPD course
(30 June-1 July 2011). Please contact Alice Travel for more information. Note: Payment of registration fees must be received before commencement of the
course.
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CANCELLATION POLICY
Cancellations must be made in writing and be received at the ALICE TRAVEL office five working days prior to the course start
Cancellations are subject to an administrative fee:
Full Meeting Cancellation: Standard EUR 200.00 - Reduced EUR 100.00
Registered attendees who do not cancel five working days prior to the course start date and do not attend, will be responsible for the full registration fee. ALICE TRAVEL reserves the right to alter the venue and dates
if necessary. If an event is cancelled ALICE TRAVEL is not responsible for airfare, hotel or other costs incurred by registrants. Registered attendees are responsible for cancelling their own hotel and travel reservations.
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You may transfer your registration to a colleague prior to the start of the event. Please notify the ALIVCE TRAVELoffice of any such substitutions as soon as possible.
IMPORTANT: Hotel and travel reservations should be made ONLY after receipt of written registration confirmation from ALICE TRAVEL. If you have not received your confirmation within five working days, please
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